NCT02661919

Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.

Assessment of the Emfit Mattress Sensor (L-4060SLC) and Monitor (DVM-GPRS-V2) and Their Acoustic and Cloud Interface Notification Capabilities as a Nocturnal Detection System for Movements Associated With Generalized Tonic-clonic Seizures.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emfit, Corp. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory factors are involved. Several ways of preventing SUDEP have been identified. These include seizure control, stress reduction, physical activity, family's ability to perform CPR, and night supervision. A mattress alarm system that monitors nocturnal seizures can alert family members of night time seizure activity. Thus, a family member could provide aid and therefore potentially avoid SUDEP. The Emfit monitor is intended to perform these tasks. Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device has a high predictive value for detection of generalized convulsions and that it can notify caregivers in the early stages of convulsive activity. This study will further investigate the upgraded (connected to a cloud server via an integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification system.

Conditions

• Epilepsy
• Seizures

Interventions

Type	Name	Description
DEVICE	Emfit mattress sensor	Patients who are being monitored in the Epilepsy Monitoring Unit will have an Emfit mattress sensor placed under their mattress and the effectiveness of the alarm system will be tested.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2016-01-25
• Last updated: 2019-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study